Bonum Certa Men Certa

European Patents Found to be Invalid and Deemed Impotent in the Highest British Court (Again)

It's about the tadalafil generic

Just gimme the hands



Summary: "Just gimme the patent," says every greedy corporation looking to ban its competition (including generics) and facilitate monopoly pricing; the problem is, the EPO keeps granting invalid patents that take a lot of time and money to formally invalidate (in courts), as Actavis v ICOS has just shown

THE number of patents granted by the U.S. Patent and Trademark Office (USPTO) declined last year after certainty associated with these patents had declined and then number of patent lawsuits had totally collapsed. We now see something similar going on in Europe. Was it inevitable? Couldn't we learn from the mistakes of American lawmakers and USPTO officials?



We are pleased to see that IP Kat (Rose Hughes) has recently been covering some cases that relate to the European Patent Office (EPO). Hughes is doing an OK job without coming across as a patent extremist like the Bristows staff at IP Kat and yesterday she wrote this article about a (British) Supreme Court outcome. Yet another EPO-granted patent has been found to be nonsense:

This morning, the UK Supreme Court delivered its decision in Actavis v ICOS [2019] USKC 15, upholding the Court of Appeal's decision that ICOS's dosage regimen patent was obvious. In doing so, the Supreme Court (in a welcome change...) has followed the previous approach of the lower courts to the question of inventive step in both the UK courts and in the jurisprudence of the EPO.

The patent in question related to tadalafil (branded as CIALIS). Tadalafil is an orally administered drug for treating sexual dysfunction. Tadalafil works in a similar way to Pfizer’s famous blockbuster drug Viagra, but with fewer side effects. The original first medical use patent for tadalafil (EP 0740668, "Daugan") and its associated SPC have both expired. The latest decision related to ICOS's patent (EP 1173181) which claimed a particular dosage regime of tadalafil. Lilly is the exclusive licensee of the patent.

In an attempt to clear the market for their own tadalafil generic, Actavis brought revocation proceedings against the ICOS/Lilly patent. Actavis argued that the claims lacked novelty and inventive step in view of the original tadalafil patent ("Daugan"). The contentious claims related to a dose regime of up to 5mg tadalafil per day. The Court of Appeal, in overturning Mr Justice Birss' decision, found the patent invalid for lack of inventive step (Actavis v ICOS [2017] EWCA Civ 1671). Particularly, it was found that the claimed dose would have been obvious for the skilled person to try (IPKat post here).


Notice that first comment which asks: "Can every one of Lord Hodge's 9 factors be accommodated within Lord Hodge's exposition of the EPO's Problem and Solution Approach? If not all, which ones not?"

“Can every one of Lord Hodge's 9 factors be accommodated within Lord Hodge's exposition of the EPO's Problem and Solution Approach?”
      --Anonymous
Someone "from France" then added: "One important factor seems indeed to be missing, which is the "reasonable expectation of success", even though certain of the listed factors are usually considered for applying this factor. The reasoning that the clinical trial is somewhat a "one way street" (to use EPO standards) is not completely out of scope, but the specific dosage finding that has been identified for optimal effect could, in my view, not have been necessarily derived from this approach (the dosage plateau could not have been expected, considering it seems to necessarily imply some hindsight). I'm not sure I agree with the comment in the post that such a decision is welcome..., I can hardly consider a diverging view between the EPO and national courts to be welcome."

Another anonymous commenter quotes: "The original first medical use patent for tadalafil (EP 0740668, "Daugan") and its associated SPC have both expired."

Then comes the question (or questions): "Doesn't this mean it has already passed through clinical trials? By the courts' logic should a 5mg dose already be known? What have I missed?"

What about public interests as well? Either way, the court has trashed yet another European Patent. Will António Campinos get the message or just keep on lying about quality?

“I can hardly consider a diverging view between the EPO and national courts to be welcome.”
      --Anonymous
Freshfields Bruckhaus Deringer LLP's Laura Whiting and Paul Abbott wrote about it this morning (publication time), calling it "its second patent decision in 6 months" (so rarely do we get to see, at least at this level, just how awful the quality of patents has become).

We'll probably hear a lot more about it in days if not weeks to come.

Recent Techrights' Posts

The Register MS Takes More Money to Boost Slop Hype, This Time From Snyk, a Notorious FUD Source
At some stage or at some point they might even decide to stop doing so
"AI" Hype or LLM Slop is Not About Efficiency, It's About Lowering Standards
It does not seem like IBM is genuinely committed to the same goals (or commitments) as the original Red Hat
If Free/Libre Software is Adding Trillions in Value to the European Economy, Then the European Commission Must Crush Software Patents
Further to what we wrote yesterday
Over at Tux Machines...
GNU/Linux news for the past day
 
Hopping From One Set of Buzzwords to the Next
Rotating hype and vapourware
Currys PCWorld Hates GNU/Linux Even Though It Runs the World
If more and more people choose to remove Windows, then Currys PCWorld will feel the financial impact of its dumb policies
Internet Relay Chat and Gemini Protocol Help Us Relive the Net of the Dial-Up Era
The kids were alright
"GPT-5" is Another Microsoft Dead Cat Trying to Bounce
The hype, the momentum (or the inertia) is wearing off
Microsoft Windows Losing Its Grip Near Turkey and Russia
The 'corridor' nations connecting Iran to Europe
Slopwatch: LinuxSecurity, Google News, and Serial Slopper (SS)
The slop, the bad, and the ugly
Links 13/08/2025: The “Incriminating Video” Scam and Corruption in South Korea
Links for the day
Gemini Links 13/08/2025: Movie Memories and Mystery Machine Bus
Links for the day
Links 13/08/2025: GitHub Trouble and Openwashing by Microsoft OSI With the Typical Buzzwords
Links for the day
Microsoft Swallows GitHub Losses
Only Microsoft knows how much money it has already lost on GitHub
Gemini Links 13/08/2025: Climate, Coffee, and Deploying Troops in Washington DC After Pardoning 1,000+ Insurrectionists in Washington DC
Links for the day
The Register MS Lowered MS Focus This Week
We hope The Register recognises its errors and tries to make up for them
Learning Ethics From Jeffrey Epstein's Enabler/Client/Ally, Coca-Cola, and Microsoft Accenture
Whatever merits vocabulary changes initially had are being tainted or obscured by later iterations, which tell us to avoid word like "normal", which apparently offend some people (so they argue)
Personal Attacks From Rust People Serve to Confirm They Have Lost the Argument
"The discussion I find around the net so far has no technical merit and centers around ad hominem"
Physical Meters and Purely Mechanical Meters Aren't Dumb; It's Dumb to Mock or Dismiss Them as Antiquated
I've learned a lot this week, both online and over the telephone
IRC Proceedings: Tuesday, August 12, 2025
IRC logs for Tuesday, August 12, 2025
GitHub Will End Up like XBox and Skype
It is not likely that the XBox franchise will survive the next 5 years
Stones Thrown in Glass Houses
Projecting? You bet!
As Europe Gets Increasingly Serious About Software Freedom and Digital Sovereignty It Needs to Enforce a Ban on Software Patents ASAP
many councils in Europe move to Free software and US policy/companies cannot be trusted
Windows 12 in Bahrain (Microsoft "Market Share" Down to 12%, an All-Time Low)
They really ought to get away from Windows even faster
The Web Needs 'Pest Control' When It Comes to LLM Slopfarms
The goal is to discourage more sites becoming slopfarms
Microsoft Can Now Stop Reporting the GitHub Layoffs (Even When They Happen)
GitHub's original staff will see the true cost of becoming "b0rged" - something that Microsoft earned a bad reputation for
How to Get Very Bad or Even Malicious Code Into Linux? Write it in a Language That Linus Torvalds and Most Other Linux Developers Don't Understand.
One point nobody brings up is, what if code gets committed while evading audits and scrutiny?
Links 12/08/2025: Wikipedia Fails at UK High Court, Perlmutter Still Fights to Squash the Slop Lobby
Links for the day
Gemini Links 12/08/2025: Field Recording and Digital Legacy
Links for the day
Links 12/08/2025: WinRAR Zero-Day, SonicWall Does More Harm Than Good
Links for the day
Links 12/08/2025: More Sabotage of Underwater Cable Ahead of Russian Alaska Summit
Links for the day
Richard Stallman Will Not Miss Microsoft GitHub, It Was Only Good at Harvesting a Lot of Code for Plagiarism-as-a-Service
investors are apparently willing to lose money for buzzwords
Slopfarms Slopping Away at "Linux" and Spreading Microsoft Misinformation
Slopfarms don't comprehend this as they lack actual comprehension, they're just parrots
Links 12/08/2025: Science, Hardware, and Ukraine Excluded From Negotiations About Its Future
Links for the day
GitHub the Company Has, in Effect, Just Died (Time to Look for Alternatives)
To Microsoft, what's left of GitHub after dismantling/folding it is some "training set" (people's code, without permission to "train" i.e. misuse under the guise of "GenAI" plagiarism)
Linux Foundation Says "Housekeeping", "Hung", "Normal", "Native Feature/Support" and "Girl/Girls" Are Offensive Words
Bombing people is OK, just use the right "terms"
It Looks More Like Microsoft GitHub Layoffs
GitHub is just losing loads of money
Gemini Links 12/08/2025: Meditation, OpenStreetMap, Smolweb, and More
Links for the day
Google News is Dying: Most of Its Top Stories Now Are LLM Slop With Slop Images (i.e. 100% Fake 'Content')
Google News has been drowning in this sort of stuff for quite some time
Over at Tux Machines...
GNU/Linux news for the past day
IRC Proceedings: Monday, August 11, 2025
IRC logs for Monday, August 11, 2025
Our Predictions Were Right: GitHub Dying as Losses Pile Up (as a Company It Cannot Continue to Exist, It's Not 'Free Hosting')
GitHub always lost money
Links 11/08/2025: Meritless Twitter Suspensions and Disney Scraps Deepfake Dwayne Johnson
Links for the day
Gemini Links 11/08/2025: Upgrading Debian Bookworm and Better Quality PDFs From Gemini Pages
Links for the day
Currys PCWorld Lied a Decade Ago, 10 Years Later It Still Effectively Voids Your Warranty for Installing GNU/Linux Despite It Being Increasingly Mainstream
Microsoft gatekeepers
Team GNOME Has Libeled Me for Nearly 20 Years
we are not dealing with sane people
Experience With Airlines in 'Web Sites' and in 'Apps'
In a lot of ways, Stallman Was Right about what JavaScript would turn out to be
Open Does Not Mean Free
wiser to ask if some program is freedom-respecting
The Register MS Takes Money From Companies Banned by the Biden and Trump Administrations (National Security Risk)
today's sponsor
Sabotaging GNU/Linux PCs (and Users) is Not a 'Joke'
maybe cruelty is the very objective
How We Process Screenshots of Slop to Suitably Tag Them as Slop
everything is a single command
Links 11/08/2025: Data Breaches, Politics, and Climate
Links for the day
Over at Tux Machines...
GNU/Linux news for the past day
IRC Proceedings: Sunday, August 10, 2025
IRC logs for Sunday, August 10, 2025
Gemini Links 11/08/2025: Tea Caffeine Hot and Super ZZ Zero
Links for the day